510(k) K060289

EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 by Frontline Medical — Product Code KNA

K060289 is an FDA 510(k) premarket notification submitted by Frontline Medical for the device "EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01". The FDA issued a decision of Substantially Equivalent on July 7, 2006. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. Frontline Medical has at least 1 other 510(k) clearance on record.